Restore-B: A Mixed-methods Trial Evaluating the Feasibility of a Multi-centre Randomised Controlled Trial Comparing No-mesh to Mesh-assisted Immediate Prepectoral Implant-based Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
研究概览
简要总结
The goal of this feasibility randomised controlled clinical trial (RCT) is to compare mesh-assisted to no-mesh pre-pectoral implant based immediate breast reconstruction in women undergoing mastectomy for treatment of breast cancer or for risk reduction of an inherited breast cancer risk.
The main questions it aims to answer are:
- To determine the feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
- To determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction.
Participants will be randomly allocated to have their breast reconstruction either with the use of mesh or without the use of mesh prior to the start of the operation. Participants will be blinded to their allocation until day 90 post operatively. Participants will be asked to have medical photography and to complete a short quality of life questionnaire before and after surgery at 90 days prior to finding out their allocation.
详细描述
Trial Design:
Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery.
Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).
Planned Trial Period:
The overall period of the trial is:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to their surgical allocation (mesh or no mesh) and will be unblinded after completion of their post-operative questionnaire at day 90.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women > 18 years
- •Participant is able and willing to give informed consent for participation in the trial
- •Eligible for immediate prepectoral implant-based breast reconstruction with implant or expander with mesh (biologic or synthetic) for cancer treatment or risk reduction surgery.
- •In the Investigator's opinion, can comply with all trial requirements.
排除标准
- •The participant may not enter the trial if any of the following apply:
- •Participant is pregnant, lactating or planning pregnancy during the trial
- •Patient refusal
- •Delayed breast reconstruction post simple mastectomy
结局指标
主要结局
Feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
时间窗: 16 months
* Number of patients eligible * Number of patients consented and randomised within 12 months recruitment * Number of patients lost to follow up/withdrawal * Completeness of data per participant (%)
次要结局
- Clinical outcomes in each arm(90 days)
- Patient reported outcome: Breast-Q Breast Reconstruction Quality of Life (QoL) Measure(90 days post operatively)
- Patient reported outcome: EuroQoL-EQ5D Quality of Life (QoL) Measure(90days post operatively)